- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of nuclear medicine outfit Advanced Accelerator Applications S.A.'s (NASDAQ:AAAP +0.7%) SomaKit TOC 40 ug for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with gastroenteropancreatic neuroendocrine tumors.
- SomaKit TOC is a radiopharmaceutical preparation of gallium edotreotide solution for injection that enables specialists to locate primary tumors and their metastases.
- A final decision by the European Commission usually takes ~60 days.
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Update: Apparently, the EMA published CHMP's positive opinion prematurely. On September 22, it announced that it removed the information from its website. Once CHMP completes its review, its final opinion will be published.